MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24686
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was broken.The target lesion was located in an arteriovenous fistula.A 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon was broken.The device was removed and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that the balloon was broken.The target lesion was located in an arteriovenous fistula.A 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon was broken.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the stenosed target lesion was 80-85% located in the mildly tortuous and severely calcified arteriovenous fistula.The balloon material broke and was removed with used of catheter sheath.
Event or Problem Description
It was reported that the balloon was broken.The target lesion was located in an arteriovenous fistula.A 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon was broken.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the stenosed target lesion was 80-85% located in the mildly tortuous and severely calcified arteriovenous fistula.The balloon material broke and was removed with used of catheter sheath.
Additional Manufacturer Narrative
H6 device codes updated from break (a0401) to material rupture (a0412).Device evaluated by mfr.: gladiator elite 8.0 x40, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 9mm proximal of the proximal markerband and extending approximately 52mm distally across the balloon material.An examination of the balloon material and markerbands identified no other issues.A visual examination of the markerbands identified no issues.A visual and tactile examination found the shaft of the device to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues or damage to the tip of the device.This concludes the product analysis.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16408628
• Report Number: 2124215-2023-07688
• Device Sequence Number: 20368945
• Product Code: LIT
• UDI-Device Identifier: 08714729809876
• UDI-Public: 08714729809876
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0028720230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 02/23/2023; 04/05/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 02/27/2023; 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 68 KG